510(k) K983268
- Device
- MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY
- Applicant
- DIAGNOSTIC REAGENTS, INC.
- 510(k) number
- K983268
- Product code
- LFH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-11-18
- Date received
- 1998-09-17
- Regulation
- 862.3910
- Classification name
- U.v. Spectrometry, Tricyclic Antidepressant Drugs
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- YUH-GENG TSAY
- Address
- 601 California Ave. Sunnyvale CA US 94086 94086
FDA Registration Numbers#
- 3010939897
- 2517506
- 2030633
- 3005333358
- 2246703
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LFH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231020 | Alinity c Tricyclic Antidepressants Reagent Kit | Microgenics Corporation | 2023-11-17 |
| K213875 | DRI TM Tricyclics Serum Tox Assay | Microgenics Corporation | 2022-12-21 |
| K981801 | ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA | Princeton BioMeditech Corp. | 1998-08-25 |
| K961393 | TRICYCLICS SERUM TOX ASSAY | Diagnostic Reagents, Inc. | 1996-06-12 |
| K953761 | AXSYM TRICYCLIC ANTIDEPRESSANTS | Abbott Laboratories | 1995-11-22 |
Legacy Summary#
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FDA Review#
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